2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12/06/1996 - 23/06/1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study (OECD 404)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Dioctyltin bis (2-EHMA), purity >98%

IUPAC Name:

Dioctyltin bis (2-EHMA), purity >98%

Constituent 2

Reference substance name:

2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate

EC Number:

239-622-4

EC Name:

2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate

Cas Number:

15571-58-1

Molecular formula:

C36H72O4S2Sn

IUPAC Name:

2-ethylhexyl 2-{[({2-[(2-ethylhexyl)oxy]-2-oxoethyl}sulfanyl)dioctylstannyl]sulfanyl}acetate

Details on test material:

Purity >98%

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:no data
- Age at study initiation:no data
- Weight at study initiation:2615-3446 g
- Housing:individually
- Diet (e.g. ad libitum): not precised, ad libitum
- Water (e.g. ad libitum): not precised, ad libitum
- Acclimation period:for a minimum of six days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):20 +/- 3
- Humidity (%):30-70%
- Air changes (per hr):no data
- Photoperiod (hrs dark / hrs light):12-h light/dark period.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

undiluted, 0.5 ml on a 6.5 cm2 area (1 x 1 inch).

Duration of treatment / exposure:

4 hours

Observation period:

12 days

Number of animals:

Four males and two females

Details on study design:

On the day to dosing, the hair was removed from the backs and flanks of the rabbits using an Oster small animal clipper. Each 0.5 ml dose was applied to an area of skin approximately 6.5 cm2 under a secured two-ply gauze patch that was overwrapped with a gauze binder and secured with Dermiform tape. Plaxtic restraint collars were applied and remained on the animals for the duration of the exposure period. Each animal received a single, four-hour, semi-occluded exposure. At the end of four ours, the collars and bandages were removed and the sites wiped with disposable paper towels moistened with deionized water. The application sites were observed for erythema, edema and other dermal findings approximately 30-60 minutes and 24, 48 and 72 hours after patch removal and once daily through day 11 if irritation persisted. Skin reactions were evaluated according to the OECD scoring system and the irritant/corrosive potency of the test substance was classified according to EC Directive 83/467/EEC.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

6 rabbits

Time point:

other: 24-48-72 hours

Score:

2.1

Max. score:

4

Reversibility:

fully reversible within: 11 days

Remarks on result:

other: Mean individual scores : 3-2-2-2-1.67-2

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

6 rabbits

Time point:

other: 24-48-72 hours

Score:

0.33

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: Mean individual scores : 1-0-0.33-0-0.33-0.33

Irritant / corrosive response data:

Six and four rabbits had slight to moderate erythema and very slight edema, respectively. Desquamation was noted for three animals. Edema completely subsided by day 6 or earlier. There were no other dermal findings. All irritation was reversible and completely subsided by day 11 or earlier. Desquamation was noted for three animals. Edema completely subsided by day 6 or earlier. All irritation was reversible and completely subsided by day 11 or earlier. The test material received a descriptive rating classification of moderately irritating.

Any other information on results incl. tables

Primary dermal irritation study in albino rabbits Individual dermal scores
0,5 ml/site
			Erythema					Edema
Animal	Sex	Site	0.5-1h	24h	48h	72h	Site	0.5-1h	24h	48h	72h
20850	M	A	2	3	3	3	A	0	1	1	1
20856	M	A	1	2	2	2	A	0	0	0	0
20873	M	A	0	2	2	2	A	0	0	0	1
20877	M	A	1	2	2	2	A	0	0	0	0
20899	F	A	1	1	2	2	A	0	0	0	1
20914	F	A	2	2	2	2	A	0	0	0	1
		Total	7	12	13	13	Total	0	1	1	4
h = hours; M = Male; F = Female

Applicant's summary and conclusion

Interpretation of results:

moderately irritating

Remarks:

Migrated information but not classified Criteria used for interpretation of results: other: Regulation EC no.1272/2008 (CLP).

Conclusions:

In this study, DOTE is irritant but it was not classified according to regulation EC no.1272/2008 (CLP).

Executive summary:

A GLP OECD Guideline 404 (Acute Dermal Irritation / Corrosion) test was carried out with DOT(2 -EHMA). The test substance was applied undiluted on a patch on shaved rabbit skin. The test material induced slight to moderate erythema on all rabbits and very slight edema on four animals. Three rabbits had desquamation. There were no other dermal findings. All irritation was reversible and completely subsided by day 11 or earlier.

Interpretations of result, according to the regulation EC no.1272/2008 (CLP), the test substance was moderately irritant but it was not classified under the experimental conditions.